RNA Disruption Assay (RDA)-Breast Cancer Response Evaluation for Individualized Therapy

NCT03524430 | Recruiting DMC

• 2 other identifiers: RnaDx-BRV-BC- 01RnaDx-BRV-BC- 02 (for Germany)
• Study Type: interventional
• Target: 801
• Locations: 7 countries
• Sites: 7

Brief Summary

The current study aims to provide validation results of RNA Disruption Assay (RDA) as a tumour response assessment tool that uses tumour core biopsies taken starting from 35 +/- 4 days after the initiation of neoadjuvant chemotherapy.

Conditions

Breast Neoplasm Female

Keywords

Breast cancer

Outcome Measures

Primary Outcomes (1)

• Pathological complete response (pCR)

  (ypT0,ypN0) / (ypTis,ypN0)

  At surgery after completion of neoadjuvant therapy

Secondary Outcomes (2)

• Disease-free survival

  5 years of survival follow-up

• Residual Cancer Burden

  At surgery

Study Arms (1)

Single Interventional Study Arm

EXPERIMENTAL

There will be 2 biopsy collection time points with 2 core needle biopsy specimens taken at each biopsy collection time point for RDA analysis during neoadjuvant chemotherapy.

Procedure: Core needle biopsy

Interventions

Core needle biopsy PROCEDURE

1st core needle biopsy for RDA (2 specimens): Time Point: 35 +/-4 days after initiation of chemotherapy. If no change is made to the therapy, a second biopsy (2 specimens) will be performed at 55 +/- 5 days after therapy initiation. If there is a change of drugs, the second biopsy (2 specimens) will be performed at \~2-3 weeks after initiation of new drugs; Timing by type of drug schedule 3-weekly: at 16 days +/- 2 days, Bi-weekly: at day of 2nd dose preferably before drug admin., Weekly: at day of 4th dose preferably before drug admin.

Single Interventional Study Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged at least 18 years;
• Patients must be able to provide informed consent and sign the informed consent form to participate in the RDA study before any study procedures starts;
• Newly diagnosed clinical stage I, II or III breast cancer with complete surgical excision of the breast cancer after neoadjuvant therapy as the treatment goal;
• Tumour size at least 1 cm in one dimension by clinical or radiographic exam (WHO criteria);
• Must have histological confirmation of invasive breast cancer of any subtype or grade;
• Patient is scheduled for neoadjuvant chemotherapy +/- antibodies and +/- other drugs according to Standard of Care;
• Patient willing to have 2 research core needle biopsies (for RDA) taken at 2 collection timepoints during neoadjuvant chemotherapy treatment.

You may not qualify if:

• Patient who has had prior local (i.e. surgery or radiotherapy) or systemic (i.e. endocrine or cytotoxic) therapy for the current breast cancer;
• Participation in another interventional clinical trial with concurrent treatment with experimental drugs to treat the current breast cancer during the period of neoadjuvant therapy (from diagnosis until surgery);
• Stage IV breast cancer;
• Bilateral or multicentric breast tumour;
• Prior malignant disease except curatively treated in-situ maligancies;
• Concurrent pregnancy;
• Breast feeding woman;
• Concurrent medical, psychiatric or addictive disorders that may limit the ability to give informed consent or complete the trial;
• Reasons indicating risk of poor compliance with study procedures;
• Patient not able to consent;

Sponsors & Collaborators

• Rna Diagnostics Inc.: lead

Study Sites (7)

Siteman Cancer Center

St Louis, Missouri, 63129, United States

RECRUITING

Sunnybrook Health Sciences Center

Toronto, Canada

RECRUITING

Institut de Cancerologie de Strasbourg

Strasbourg, France

RECRUITING

Universitätsklinikum Münster

Münster, Germany

RECRUITING

SST di Cremona Multidisciplinare di Patologia Mammaria, Italy

Cremona, Italy

RECRUITING

NZOZ Neuromed

Lublin, Poland

RECRUITING

Hospital U. 12 de Octubre

Madrid, Spain

RECRUITING

Related Publications (5)

• Parissenti AM, Guo B, Pritzker LB, Pritzker KP, Wang X, Zhu M, Shepherd LE, Trudeau ME. Tumor RNA disruption predicts survival benefit from breast cancer chemotherapy. Breast Cancer Res Treat. 2015 Aug;153(1):135-44. doi: 10.1007/s10549-015-3498-9. Epub 2015 Jul 25.

  PMID: 26208483 BACKGROUND

• Narendrula R, Mispel-Beyer K, Guo B, Parissenti AM, Pritzker LB, Pritzker K, Masilamani T, Wang X, Lanner C. RNA disruption is associated with response to multiple classes of chemotherapy drugs in tumor cell lines. BMC Cancer. 2016 Feb 24;16:146. doi: 10.1186/s12885-016-2197-1.

  PMID: 26911141 BACKGROUND

• Toomey S, Eustace AJ, Pritzker LB, Pritzker KP, Fay J, O'Grady A, Cummins R, Grogan L, Kennedy J, O'Connor D, Young L, Kay EW, O'Donovan N, Gallagher WM, Kalachand R, Crown J, Hennessy BT. RE: RNA Disruption Assay as a Biomarker of Pathological Complete Response in Neoadjuvant Trastuzumab-Treated Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer. J Natl Cancer Inst. 2016 Jul 4;108(8):djw111. doi: 10.1093/jnci/djw111. Print 2016 Aug. No abstract available.

  PMID: 27377904 BACKGROUND

• Pritzker K, Pritzker L, Generali D, Bottini A, Cappelletti MR, Guo B, Parissenti A, Trudeau M. RNA Disruption and Drug Response in Breast Cancer Primary Systemic Therapy. J Natl Cancer Inst Monogr. 2015 May;2015(51):76-80. doi: 10.1093/jncimonographs/lgv015.

  PMID: 26063893 BACKGROUND

• Cazzaniga ME, Ademuyiwa F, Petit T, Tio J, Generali D, Ciruelos EM, Califaretti N, Poirier B, Ardizzoia A, Hoenig A, Lex B, Mouret-Reynier MA, Giesecke D, Isambert N, Masetti R, Pitre L, Wrobel D, Augereau P, Milani M, Rask S, Solbach C, Pritzker L, Noubir S, Parissenti A, Trudeau ME. Low RNA disruption during neoadjuvant chemotherapy predicts pathologic complete response absence in patients with breast cancer. JNCI Cancer Spectr. 2024 Jan 4;8(1):pkad107. doi: 10.1093/jncics/pkad107.

  PMID: 38113421 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Biopsy, Large-Core Needle

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques

Study Officials

• Maureen Trudeau, MD

  Sunnybrook Health Sciences Center, Toronto, Canada

  PRINCIPAL INVESTIGATOR

• Daniele Generali, MD

  SST di Cremona Multidisciplinare di Patologia Mammaria, Italy

  PRINCIPAL INVESTIGATOR

• Foluso Ademuyiwa, MD

  Washington University School of Medicine, St Louis, USA

  PRINCIPAL INVESTIGATOR

• Thierry Petit, MD

  Institut de Cancérologie, Strasbourg, France

  PRINCIPAL INVESTIGATOR

• Joke Tio, MD

  Munster, Germany

  PRINCIPAL INVESTIGATOR

• Eva Ciruelos, MD

  Madrid, Spain

  PRINCIPAL INVESTIGATOR

• Tomasz Jankowski, MD

  NZOZ Neuromed, Lublin, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanaa Noubir, PhD

CONTACT

1-416-333-2931; snoubir@rnadiagnostics.com

John Connolly

CONTACT

1-416-985-4361; jconnolly@rnadiagnostics.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is a diagnostic study. The RDI operator that assesses patient response to therapy using the RDA test is blinded to patient outcome. The clinicians and patients will not receive the RDI score in order to not act on the RDA test result (because this is an investigational study).
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2018
• First Posted: May 14, 2018
• Study Start: April 26, 2018
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): March 31, 2031
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); IT (1); PL (1); CA (1); ES (1); FR (1); US (1)